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WARNING: Electrical Shock Hazard - Do not remove Ultiri Measurement
System covers. To avoid electrical shock, use only the power cord supplied
with the system and connect only to properly grounded wall outlets. Refer to
"Setting Up the System" and "Safety Information" for electrical safety
information.
WARNING: Do not use the PressureWire™ X Guidewire if there are any signs
of damage.
CAUTION: Please note Abbott Medical makes no representation or warranty
that use of the Ultiri Measurement System complies with applicable privacy,
security, and confidentiality laws, but encourages you to assess your own risk
as you use, disclose, control, process, or transfer patient health information
with the Ultiri Measurement System.
•
Use only compatible wireless PressureWire X Guidewires to report aortic
distal pressure. Always use under appropriate imaging guidance
(endoscopy, x-ray fluoroscopy, or other appropriate guidance method).
•
Always read and follow the Instructions for Use supplied with the
PressureWire X Guidewire.
•
Always use controls, make adjustments, and perform procedures as
specified in these Instructions for Use.
Avoiding Electrical Hazards
WARNING: To maintain compliance with regulatory standards, all components
supplied with the system or specified as part of the system are to be powered
by power supplies and power cords provided with the system. No unauthorized
substitutions are permitted.
When transferring files inside the catheterization laboratory, use only
port-powered USB drives.
WARNING: Inside the catheterization laboratory only port-powered USB
drives may be connected to the USB port. Connecting externally powered
devices to the USB port in the patient vicinity may compromise electrical
isolation and cause patient injury.
Note: Outside the catheterization laboratory, IEC 60950/IEC 62368-1
compliant, externally powered USB hard drives may be connected to the
USB port.
Do not remove system covers. Only qualified personnel should service the
system. Accidentally contacting the electrical circuits inside the housing could
cause serious injury.
Ultiri™ Measurement System Operation Manual – 600327583 Rev. A
Safety Information
7
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